Why it was recalled
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Product description
RISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton, ASIN B08JCWG84D, barcode X002NI8PE1.
Lot numbers, UPCs & expiration codes
Lot # 48658908, Exp. date 09/09/2023
Where it was sold
Product was distributed nationwide via the internet through Amazon Marketplace.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0645-2022
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Feb 10, 2022
- FDA report date
- Mar 2, 2022
- Quantity
- 5,500 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Positive Health
Original FDA data
Every field from FDA enforcement report D-0645-2022, exactly as published.
Show all FDA fields
- City
- Wilmington
- State
- DE
- Status
- Terminated
- Country
- United States
- Event ID
- 89606
- Address
- 1013 Centre Rd
- Address (line 2)
- Suite 403B
- Code information
- Lot # 48658908, Exp. date 09/09/2023
- Postal code
- 19805-1265
- Report date
- Mar 2, 2022
- Product type
- Drugs
- Recall number
- D-0645-2022
- Classification
- Class I
- Recalling firm
- Positive Health
- Product quantity
- 5,500 cartons
- Termination date
- Jun 3, 2022
- Reason for recall
- Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- RISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton, ASIN B08JCWG84D, barcode X002NI8PE1.
- Distribution pattern
- Product was distributed nationwide via the internet through Amazon Marketplace.
- Recall initiation date
- Feb 10, 2022
- Initial firm notification
- Press Release
- Center classification date
- Mar 4, 2022